Jeffrey Cheah School of Medicine and Health Sciences, Monash University Malaysia, Bandar Sunway, Selangor 47500, Malaysia.
Nutrients. 2021 Jan 18;13(1):258. doi: 10.3390/nu13010258.
Diabetic kidney disease (DKD) is a debilitating complication of diabetes, which develops in 40% of the diabetic population and is responsible for up to 50% of end-stage renal disease (ESRD). Tocotrienols have shown to be a potent antioxidant, anti-inflammatory, and antifibrotic agent in animal and clinical studies. This study evaluated the effects of 400 mg tocotrienol-rich vitamin E supplementation daily on 59 DKD patients over a 12-month period. Patients with stage 3 chronic kidney disease (CKD) or positive urine microalbuminuria (urine to albumin creatinine ratio; UACR > 20-200 mg/mmol) were recruited into a randomized, double-blind, placebo-controlled trial. Patients were randomized into either intervention group ( = 31) which received tocotrienol-rich vitamin E (Tocovid SupraBio; Hovid Berhad, Ipoh, Malaysia) 400 mg daily or a placebo group which received placebo capsules ( = 28) for 12 months. HbA1c, renal parameters (i.e., serum creatinine, eGFR, and UACR), and serum biomarkers were collected at intervals of two months. Tocovid supplementation significantly reduced serum creatinine levels (MD: -4.28 ± 14.92 vs. 9.18 ± 24.96), = 0.029, and significantly improved eGFR (MD: 1.90 ± 5.76 vs. -3.29 ± 9.24), = 0.011 after eight months. Subgroup analysis of 37 patients with stage 3 CKD demonstrated persistent renoprotective effects over 12 months; Tocovid improved eGFR (MD: 4.83 ± 6.78 vs. -1.45 ± 9.18), = 0.022 and serum creatinine (MD: -7.85(20.75) vs. 0.84(26.03), = 0.042) but not UACR. After six months post washout, there was no improvement in serum creatinine and eGFR. There were no significant changes in the serum biomarkers, TGF-β1 and VEGF-A. Our findings verified the results from the pilot phase study where tocotrienol-rich vitamin E supplementation at two and three months improved kidney function as assessed by serum creatinine and eGFR but not UACR.
糖尿病肾病（DKD）是糖尿病的一种使人虚弱的并发症，它发生在 40%的糖尿病患者中，导致多达 50%的终末期肾病（ESRD）。生育三烯酚在动物和临床研究中已被证明是一种有效的抗氧化剂、抗炎剂和抗纤维化剂。本研究评估了每天补充 400 毫克富含生育三烯酚的维生素 E 对 59 例 DKD 患者的影响，为期 12 个月。招募了患有 3 期慢性肾脏病（CKD）或尿微量白蛋白尿阳性（尿白蛋白肌酐比；UACR > 20-200mg/mmol）的患者进入一项随机、双盲、安慰剂对照试验。患者被随机分为干预组（n=31），每天接受富含生育三烯酚的维生素 E（Tocovid SupraBio；Hovid Berhad，怡保，马来西亚）400 毫克，或安慰剂组（n=28），接受安慰剂胶囊，持续 12 个月。每隔两个月采集一次糖化血红蛋白、肾脏参数（即血清肌酐、eGFR 和 UACR）和血清生物标志物。Tocovid 补充剂显著降低了血清肌酐水平（MD：-4.28 ± 14.92 与 9.18 ± 24.96，=0.029），并显著改善了 eGFR（MD：1.90 ± 5.76 与-3.29 ± 9.24，=0.011），持续 8 个月。对 37 例 3 期 CKD 患者的亚组分析表明，在 12 个月内持续具有肾脏保护作用；Tocovid 改善了 eGFR（MD：4.83 ± 6.78 与-1.45 ± 9.18，=0.022）和血清肌酐（MD：-7.85(20.75) 与 0.84(26.03)，=0.042），但对 UACR 没有影响。洗脱后 6 个月，血清肌酐和 eGFR 没有改善。血清生物标志物 TGF-β1 和 VEGF-A 没有显著变化。我们的发现证实了前期研究的结果，即补充富含生育三烯酚的维生素 E 在两个月和三个月时可改善肾功能，血清肌酐和 eGFR 得到改善，但 UACR 没有改善。
